Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

Sanofi

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Lixisenatide (AVE0010)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01572649

PKD11475

2011-004584-67 (EudraCT Number)

U1111-1124-3136 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

• To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls

Secondary Objectives:

• To evaluate in both paediatric and adult populations:

• the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses
• the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast
• safety and tolerability.

Full description

The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose administration.

Enrollment: 24 patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year (adults) and at least 3 months for paediatric population at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization)
• HbA1c ≥ 7% and ≤ 10% at screening
• Age eligibility for paediatric population: ≥ 10 years and <18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: ≥ 18 and ≤ 65 years
• For paediatric population:body weight >50kg, BMI >85th percentile for age and gender and BMI ≤ 50 kg/m²
• For adults: BMI > 25 kg/m2 and ≤ 37 kg/m2

Exclusion criteria:

• If female, pregnancy (defined as positive serum pregnancy test), breast-feeding
• Diabetes other than type 2 diabetes
• Positive test for insulinoma associated protein (IA2) and glutamic acid decarboxylase (GAD) autoantibodies
• Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening
• Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) or to metacresol
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
• Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

24 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously

Treatment:

Drug: Placebo

Dose 1

Experimental group

Description:

1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously

Treatment:

Drug: Lixisenatide (AVE0010)

Dose 2

Experimental group

Description:

1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously

Treatment:

Drug: Lixisenatide (AVE0010)